FibromyalgiaNCT06001034
Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
A study testing Occlusion training in people with Fibromyalgia, run by José Carlos Rodríguez Bautista at 1 site in Spain.
Trial summary
Occlusive training in people with fibromyalgia Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Occlusion training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2022to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).
- o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9.
- Symptoms have been present, at a similar level, during the last three months.
- The patient has no other pathology that could explain the pain.
- Recent negative COVID-19 test.
Who cannot join
- Other associated pathologies that may hinder the development of the research.
- Mobility limitations.
- Injuries that add to those of the disease itself and hinder mobility.
- No medical evaluation of the diagnosis of the disease.
- Negative results in the inclusion tests.
- Cardiac pathologies.
- Blood pressure higher than 130-90 mmHg.
- No COVID-19 test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 9-week Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia in a Hospital Setting, and Its Impact on Blood/Plasma Variables, Quality of Life and Functional Autonomy.
Occlusive training in people with fibromyalgia
Read the detailed description
Intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. The study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
- Conditions
- Fibromyalgia
- Being tested
- Occlusion training
- Keywords
- occlusive training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion trainingDevice
Also called Occlusive cuffing during aerobic exercise in participants with fibromyalgia
Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Aerobic exercise plus occlusive tool. | Experimental | Performing low-impact aerobic exercise with an occlusive tool 2 days per week. Receives: Device: Occlusion training |
| Group 2: Aerobic exercise without occlusive tool. | No intervention | Performing low-impact aerobic exercise without an occlusive tool 2 days per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Coenzyme Q10 after a 9-week intervention period.
Coenzyme Q10
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in total antioxidants after a 9-week intervention period.
TAS
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in disease impact questionnaire WPI after a 9-week intervention period.
WPI; score between (0-19). The higher the score, the greater the impact of the disease.
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in disease impact questionnaire SSscore after a 9-week intervention period.
SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in disease impact questionnaire FIQ after a 9-week intervention period.
FIQ; score between (0-100). The higher the score, the greater the impact of the disease
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in high density lipoproteins after a 9-week intervention period.
HDL
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in low density lipoproteins after a 9-week intervention period.
LDL
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in total cholesterol lipoproteins after a 9-week intervention period.
CHOL
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in triglycerides after a 9-week intervention period.
TG
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Changes in urea after a 9-week intervention period.
Urea
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Changes in creatinine after a 9-week intervention period.
Creatinine
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in gamma-glutamyl transferase after a 9-week intervention period.
GGT
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in glutamic-pyruvic transaminase after a 9-week intervention period.
GPT
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
GOT
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in alkaline phosphatase after a 9-week intervention period.
ALP
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in funcional test after a 9-week intervention period.
6-minute walking test
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Change in funcional test after a 9-week intervention period.
incremental shuttle walking test
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Change in funcional test after a 9-week intervention period.
30 second chair and stand test
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in funcional test after a 9-week intervention period.
Time and go test
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Change in malondialdehyde after a 9-week intervention period.
MDA (malondialdehyde)
Measured: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Change in distance traveled after a 9-week intervention period.
Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.
Measured: From week 1 to week 9 of the intervention period.
Change in visual pain scale VAS over a 9-week intervention period.
Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Measured: From week 1 to week 9 of the intervention period.
Change in perceived exertion scale BORG over a 9-week intervention period.
Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Measured: From week 1 to week 9 of the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Sep 2022
- Primary completion5 Feb 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Carlos Rodríguez Bautista
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pablo de Olavide, Hospital Universitario de Valme, Andaluz Health Service
- Responsible party
- Sponsor-investigator, José Carlos Rodríguez Bautista, Universidad Pablo de Olavide
- Investigators
- José Carlos Rodríguez Bautista, PhD currently, Principal investigator, Universidad Pablo de Olavide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001034
- Sponsor's protocol ID
- 1441-23
- Other IDs
- 0560-N-22
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Numeric code to each participant, concealing their personal data at all times.
Publications
Latorre-Roman PA, Segura-Jimenez V, Aparicio VA, Santos E Campos MA, Garcia-Pinillos F, Herrador-Colmenero M, Alvarez-Gallardo IC, Delgado-Fernandez M. Ageing influence in the evolution of strength and muscle mass in women with fibromyalgia: the al-Andalus project. Rheumatol Int. 2015 Jul;35(7):1243-50. doi: 10.1007/s00296-015-3213-5. Epub 2015 Jan 24.
PubMed 25617055Bonaterra GA, Then H, Oezel L, Schwarzbach H, Ocker M, Thieme K, Di Fazio P, Kinscherf R. Morphological Alterations in Gastrocnemius and Soleus Muscles in Male and Female Mice in a Fibromyalgia Model. PLoS One. 2016 Mar 17;11(3):e0151116. doi: 10.1371/journal.pone.0151116. eCollection 2016.
PubMed 26986947Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL, Feldman D, Natour J. Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol. 2002 Feb;29(2):353-7.
PubMed 11842825Koca I, Savas E, Ozturk ZA, Boyaci A, Tutoglu A, Alkan S, Yildiz H, Kimyon G. The evaluation in terms of sarcopenia of patients with fibromyalgia syndrome. Wien Klin Wochenschr. 2016 Nov;128(21-22):816-821. doi: 10.1007/s00508-015-0821-8. Epub 2015 Jul 4.
PubMed 26142171Shang Y, Gurley K, Symons B, Long D, Srikuea R, Crofford LJ, Peterson CA, Yu G. Noninvasive optical characterization of muscle blood flow, oxygenation, and metabolism in women with fibromyalgia. Arthritis Res Ther. 2012 Nov 1;14(6):R236. doi: 10.1186/ar4079.
PubMed 23116302Sarifakioglu B, Guzelant AY, Guzel EC, Guzel S, Kiziler AR. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients. Rheumatol Int. 2014 Oct;34(10):1361-7. doi: 10.1007/s00296-014-2978-2. Epub 2014 Mar 9.
PubMed 24610539Cordero MD, de Miguel M, Moreno-Fernandez AM. [Mitochondrial dysfunction in fibromyalgia and its implication in the pathogenesis of disease]. Med Clin (Barc). 2011 Mar 12;136(6):252-6. doi: 10.1016/j.medcli.2010.01.030. Epub 2010 Apr 24. Spanish.
PubMed 20417529Sprott H, Salemi S, Gay RE, Bradley LA, Alarcon GS, Oh SJ, Michel BA, Gay S. Increased DNA fragmentation and ultrastructural changes in fibromyalgic muscle fibres. Ann Rheum Dis. 2004 Mar;63(3):245-51. doi: 10.1136/ard.2002.004762.
PubMed 14962957Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.
PubMed 23600892Emerling BM, Weinberg F, Snyder C, Burgess Z, Mutlu GM, Viollet B, Budinger GR, Chandel NS. Hypoxic activation of AMPK is dependent on mitochondrial ROS but independent of an increase in AMP/ATP ratio. Free Radic Biol Med. 2009 May 15;46(10):1386-91. doi: 10.1016/j.freeradbiomed.2009.02.019. Epub 2009 Mar 3.
PubMed 19268526Laderoute KR, Amin K, Calaoagan JM, Knapp M, Le T, Orduna J, Foretz M, Viollet B. 5'-AMP-activated protein kinase (AMPK) is induced by low-oxygen and glucose deprivation conditions found in solid-tumor microenvironments. Mol Cell Biol. 2006 Jul;26(14):5336-47. doi: 10.1128/MCB.00166-06.
PubMed 16809770Collado-Mateo D, Dominguez-Munoz FJ, Adsuar JC, Merellano-Navarro E, Olivares PR, Gusi N. Reliability of the Timed Up and Go Test in Fibromyalgia. Rehabil Nurs. 2018 Jan/Feb;43(1):35-39. doi: 10.1002/rnj.307.
PubMed 27781288Heredia-Jimenez J, Latorre-Roman P, Santos-Campos M, Orantes-Gonzalez E, Soto-Hermoso VM. Spatio-temporal gait disorder and gait fatigue index in a six-minute walk test in women with fibromyalgia. Clin Biomech (Bristol). 2016 Mar;33:1-6. doi: 10.1016/j.clinbiomech.2016.01.009. Epub 2016 Feb 2.
PubMed 26878719Pankoff BA, Overend TJ, Lucy SD, White KP. Reliability of the six-minute walk test in people with fibromyalgia. Arthritis Care Res. 2000 Oct;13(5):291-5. doi: 10.1002/1529-0131(200010)13:53.0.co;2-x.
PubMed 14635298Salvi D, Poffley E, Orchard E, Tarassenko L. The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation. JMIR Mhealth Uhealth. 2020 Jan 3;8(1):e13756. doi: 10.2196/13756.
PubMed 31899457
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 9-week Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia in a Hospital Setting, and Its Impact on Blood/Plasma Variables, Quality of Life and Functional Autonomy.
- ClinicalTrials.gov ID
- NCT06001034
- Acronym / sponsor ID
- 1441-23
- Conditions
- Fibromyalgia
- Keywords
- occlusive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- José Carlos Rodríguez BautistaUniversity, hospital or other
- Collaborators
- Universidad Pablo de Olavide, Hospital Universitario de Valme, Andaluz Health Service
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Occlusive training in people with fibromyalgia
Detailed description
Intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. The study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Aerobic exercise plus occlusive tool. | Experimental | Device: Occlusion trainingPerforming low-impact aerobic exercise with an occlusive tool 2 days per week. |
| Group 2: Aerobic exercise without occlusive tool. | No intervention | –Performing low-impact aerobic exercise without an occlusive tool 2 days per week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).
- o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9.
- Symptoms have been present, at a similar level, during the last three months.
- The patient has no other pathology that could explain the pain.
- Recent negative COVID-19 test.
Key exclusion criteria (8 listed)
- Other associated pathologies that may hinder the development of the research.
- Mobility limitations.
- Injuries that add to those of the disease itself and hinder mobility.
- No medical evaluation of the diagnosis of the disease.
- Negative results in the inclusion tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusion trainingAlso: Occlusive cuffing during aerobic exercise in participants with fibromyalgiaImpact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia. | Device | Group 1: Aerobic exercise plus occlusive tool. |
Primary outcome
Change in Coenzyme Q10 after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Coenzyme Q10
Change in total antioxidants after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
TAS
Change in disease impact questionnaire WPI after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
WPI; score between (0-19). The higher the score, the greater the impact of the disease.
Change in disease impact questionnaire SSscore after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.
Change in disease impact questionnaire FIQ after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
FIQ; score between (0-100). The higher the score, the greater the impact of the disease
Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.
Change in high density lipoproteins after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
HDL
Change in low density lipoproteins after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
LDL
Change in total cholesterol lipoproteins after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
CHOL
Change in triglycerides after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
TG
Changes in urea after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Urea
Changes in creatinine after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Creatinine
Change in gamma-glutamyl transferase after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
GGT
Change in glutamic-pyruvic transaminase after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
GPT
Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
GOT
Change in alkaline phosphatase after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
ALP
Change in funcional test after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
6-minute walking test
Change in funcional test after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
incremental shuttle walking test
Change in funcional test after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
30 second chair and stand test
Change in funcional test after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Time and go test
Change in malondialdehyde after a 9-week intervention period.
Time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
MDA (malondialdehyde)
Change in distance traveled after a 9-week intervention period.
Time frame: From week 1 to week 9 of the intervention period.
Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.
Change in visual pain scale VAS over a 9-week intervention period.
Time frame: From week 1 to week 9 of the intervention period.
Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Change in perceived exertion scale BORG over a 9-week intervention period.
Time frame: From week 1 to week 9 of the intervention period.
Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 25617055Latorre-Roman PA, Segura-Jimenez V, Aparicio VA, Santos E Campos MA, Garcia-Pinillos F, Herrador-Colmenero M, Alvarez-Gallardo IC, Delgado-Fernandez M. Ageing influence in the evolution of strength and muscle mass in women with fibromyalgia: the al-Andalus project. Rheumatol Int. 2015 Jul;35(7):1243-50. doi: 10.1007/s00296-015-3213-5. Epub 2015 Jan 24.
- Background: PubMed 26986947Bonaterra GA, Then H, Oezel L, Schwarzbach H, Ocker M, Thieme K, Di Fazio P, Kinscherf R. Morphological Alterations in Gastrocnemius and Soleus Muscles in Male and Female Mice in a Fibromyalgia Model. PLoS One. 2016 Mar 17;11(3):e0151116. doi: 10.1371/journal.pone.0151116. eCollection 2016.
- Background: PubMed 11842825Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL, Feldman D, Natour J. Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol. 2002 Feb;29(2):353-7.
- Background: PubMed 26142171Koca I, Savas E, Ozturk ZA, Boyaci A, Tutoglu A, Alkan S, Yildiz H, Kimyon G. The evaluation in terms of sarcopenia of patients with fibromyalgia syndrome. Wien Klin Wochenschr. 2016 Nov;128(21-22):816-821. doi: 10.1007/s00508-015-0821-8. Epub 2015 Jul 4.
- Background: PubMed 23116302Shang Y, Gurley K, Symons B, Long D, Srikuea R, Crofford LJ, Peterson CA, Yu G. Noninvasive optical characterization of muscle blood flow, oxygenation, and metabolism in women with fibromyalgia. Arthritis Res Ther. 2012 Nov 1;14(6):R236. doi: 10.1186/ar4079.
- Background: PubMed 24610539Sarifakioglu B, Guzelant AY, Guzel EC, Guzel S, Kiziler AR. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients. Rheumatol Int. 2014 Oct;34(10):1361-7. doi: 10.1007/s00296-014-2978-2. Epub 2014 Mar 9.
- Background: PubMed 20417529Cordero MD, de Miguel M, Moreno-Fernandez AM. [Mitochondrial dysfunction in fibromyalgia and its implication in the pathogenesis of disease]. Med Clin (Barc). 2011 Mar 12;136(6):252-6. doi: 10.1016/j.medcli.2010.01.030. Epub 2010 Apr 24. Spanish.
- Background: PubMed 14962957Sprott H, Salemi S, Gay RE, Bradley LA, Alarcon GS, Oh SJ, Michel BA, Gay S. Increased DNA fragmentation and ultrastructural changes in fibromyalgic muscle fibres. Ann Rheum Dis. 2004 Mar;63(3):245-51. doi: 10.1136/ard.2002.004762.
- Background: PubMed 23600892Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.
- Background: PubMed 19268526Emerling BM, Weinberg F, Snyder C, Burgess Z, Mutlu GM, Viollet B, Budinger GR, Chandel NS. Hypoxic activation of AMPK is dependent on mitochondrial ROS but independent of an increase in AMP/ATP ratio. Free Radic Biol Med. 2009 May 15;46(10):1386-91. doi: 10.1016/j.freeradbiomed.2009.02.019. Epub 2009 Mar 3.
- Background: PubMed 16809770Laderoute KR, Amin K, Calaoagan JM, Knapp M, Le T, Orduna J, Foretz M, Viollet B. 5'-AMP-activated protein kinase (AMPK) is induced by low-oxygen and glucose deprivation conditions found in solid-tumor microenvironments. Mol Cell Biol. 2006 Jul;26(14):5336-47. doi: 10.1128/MCB.00166-06.
- Background: PubMed 27781288Collado-Mateo D, Dominguez-Munoz FJ, Adsuar JC, Merellano-Navarro E, Olivares PR, Gusi N. Reliability of the Timed Up and Go Test in Fibromyalgia. Rehabil Nurs. 2018 Jan/Feb;43(1):35-39. doi: 10.1002/rnj.307.
- 30-second chair standLink provided by the sponsor.
- Timed Up and Go testLink provided by the sponsor.
- 6-Minute Walk testLink provided by the sponsor.
- Incremental Shuttle Walk TestLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Numeric code to each participant, concealing their personal data at all times.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Carlos Rodríguez Bautista, PhD currently principal investigator
Universidad Pablo de Olavide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusion training in people with Fibromyalgia, run by José Carlos Rodríguez Bautista at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Coenzyme Q10 after a 9-week intervention period. (time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001034, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.